Efficacy Study of Adalimumab to Treat Interstitial Cystitis

• ClinicalTrials.gov Identifier: NCT01295814
• Recruitment Status: Completed
• First Posted: February 15, 2011
• Results First Posted: July 16, 2015
• Last Update Posted: July 16, 2015
• Sponsor: ICStudy, LLC
• Collaborator: Abbott
• Information provided by (Responsible Party): Philip C. Bosch, M.D., ICStudy, LLC

Study Description

Brief Summary:

The purpose of this study is to evaluate an investigational treatment for interstitial cystitis. Interstitial cystitis is a chronic bladder disease that includes the following symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and bladder discomfort relieved by voiding.

Presently, there is no cure for interstitial cystitis. The response to current treatments is poor. Patients with interstitial cystitis have a poorer quality of life. The cause of interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for improving the symptoms of patients with interstitial cystitis. Humira® is an injectable anti-inflammatory medication that has been available for use since December 31, 2002. Humira® has been FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases have similar characteristics to interstitial cystitis. This study will evaluate an investigational use of Humira® for the treatment of interstitial cystitis.

Condition or disease	Intervention/treatment	Phase
Interstitial Cystitis	Drug: Adalimumab; Other: inactive drug	Phase 3

Detailed Description:

Interstitial cystitis (IC) is a chronic disabling bladder syndrome characterized by urinary frequency, nocturia, urinary urgency, and pain with bladder filling-relieved by emptying. There is no cure for IC and the treatment options are suboptimal. Patients with IC report significant negative effects on their physical and mental quality of life. The etiology of IC is unknown. Certain aspects of IC suggest that autoimmunity may play a role in initiating or sustaining the chronic inflammatory response. Bladder biopsies of patients with IC demonstrate an increase number of mast cells. Mast cell activation with the release of tumor necrosis factor (TNF) may mediate this bladder inflammation. Humira® (adalimumab) is a medication that blocks the effect of TNF. Humira® (adalimumab) is FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases are similar to IC. In this study, the hypothesis being tested is that Humira® (adalimumab) will show efficacy at reducing the symptoms of IC.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)
• Study Start Date: March 2011
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: adalimumab; Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks	Drug: Adalimumab; 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period; Other Name: Humira
Placebo Comparator: Inactive drug; Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks	Other: inactive drug; 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period; Other Name: placebo

Outcome Measures

Primary Outcome Measures :

1. O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score [ Time Frame: Baseline/12 Weeks ]
   Improvement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms)

Secondary Outcome Measures :

1. Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: Baseline/ 12 weeks ]
   Improvement in O'Leary Sant Interstitial Cystitis Symptom Index (ICSI) Total scores on a range scale: 0-20 (0, meaning no symptoms, to 20, meaning the most severe symptoms)
2. Interstitial Cystitis Problem Index (ICPI) [ Time Frame: Baseline/12 Weeks ]
   Improvement in O'Leary Sant Interstitial Cystitis Problem Index (ICPI) Total scores on a scale: 0-16 (0, meaning no symptoms, to 16, meaning the most severe symptoms)
3. Pelvic Pain Urgency/Frequency (PUF) Score [ Time Frame: Baseline12 Weeks ]
   Pelvic Pain, Urgency/Frequency Symptom Scale Total scores on a scale range: 0-35 (0, meaning no symptoms, to 35, meaning the most severe symptoms)
4. Global Response Assessment (GRA) [ Time Frame: Measured at12 Weeks ]

   Percent(%) of patients who reported 50% or greater overall improvement in their condition.

   Score on a scale range (improvement 0%-100%)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Males or females ≥18 and ≤ 65 years of age previously diagnosed with Interstitial Cystitis
• Currently have symptoms of urinary urgency, frequency or pain for more than 6 months
• Urinating at least 7 times a day or having some urgency or pain (measured on linear analog scales)
• Must be post-menopausal or surgically sterile or willing to use an adequate form of birth control
• Not pregnant or lactating
• Capable of voiding independently
• Willing to provide informed consent to participate

Exclusion Criteria:

• Have symptoms that are presently relieved on other medications for interstitial cystitis
• Have absence of nocturia
• Have symptoms that are relieved by antimicrobials or antibiotics.
• Have a body mass index (BMI) of >39 kg/m2
• Have uncontrolled hypertension
• Have Type I or type 2 diabetes
• Have active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B) at Screening
• Have a positive tuberculosis test at screening
• Have had a urinary tract infection for 6 weeks
• Have had bacterial cystitis in previous 3 months
• Have had previous exposure to Humira® (adalimumab)
• Have taken investigational medication within 30 days of screening
• Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
• Are unable or unwilling to comply with protocol requirements

Contacts and Locations

Locations

United States, California

Philip C. Bosch, MD

Escondido, California, United States, 92025

Sponsors and Collaborators

ICStudy, LLC

Abbott

Investigators

• Principal Investigator: Philip C Bosch, MD

More Information

Publications of Results:

Bosch PC. A randomized, double-blind, placebo controlled trial of adalimumab for interstitial cystitis/bladder pain syndrome. J Urol. 2014 Jan;191(1):77-82. doi: 10.1016/j.juro.2013.06.038. Epub 2013 Jun 20.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

• Responsible Party: Philip C. Bosch, M.D., Urologist, ICStudy, LLC
• ClinicalTrials.gov Identifier: NCT01295814
• Other Study ID Numbers: IMM 10-0061
• First Posted: February 15, 2011
• Results First Posted: July 16, 2015
• Last Update Posted: July 16, 2015
• Last Verified: July 2015

Keywords provided by Philip C. Bosch, M.D., ICStudy, LLC:

Interstitial cystitis; Humira; Adalimumab

Additional relevant MeSH terms:

Cystitis; Cystitis, Interstitial; Urinary Bladder Diseases; Urologic Diseases; Adalimumab; Anti-Inflammatory Agents; Antirheumatic Agents